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DrugCendR Announces Pancreatic Cancer Clinical Trial

Data, New Member of Board of Directors and FDA


Orphan Drug Designation

La Jolla, CA (January 31, 2018) - DrugCendR Inc., a clinical-stage biopharmaceutical company


dedicated to developing next generation cancer therapies designed to overcome the barriers of
drug delivery in solid tumors, reported today positive progress with its ongoing pancreatic
cancer clinical trial. In addition, the lead program received orphan-drug designation from the
US Food and Drug administration (FDA) in pancreatic cancer. The company also announced a
new member of board of directors.

The ongoing clinical trial in metastatic pancreatic cancer patients (CEND1-001, Clinical trial
reference NCT03517176) has been accruing patients rapidly – the first Phase 2a -type expansion
cohort for early efficacy is now open. The study is expected to be fully enrolled with at least 30
patients in the second quarter of 2019. The early results are reportedly encouraging, with high
response rates as well as favorable safety profile, with no dose-limiting toxicities. "The progress
with the pancreatic cancer trial has exceeded our expectations” said Harri Jarvelainen, Chief
Operating Officer of DrugCendR Inc. “Our near term goal is to validate the CEND-1 platform
technology in multiple indications so clinicians can treat patients with cancers with high unmet
medical need more effectively."

Receiving the FDA orphan drug designation was also announced today. It is a significant
development milestone as it can facilitate the future development through several benefits
such as tax credits for qualified clinical trials costs, exemptions from certain FDA application
fees, and seven years of market exclusivity upon regulatory product approval. The FDA grants
orphan drug designation to drugs and biologics that are intended for the treatment of rare
diseases that affect fewer than 200,000 people in the U.S.

Lastly, the company announced that it has appointed Heidi Henson, an industry veteran, to its
Board of Directors. “I am pleased to welcome Heidi Henson to our board, where her extensive
expertise in financial management and strategy will be a major asset to DrugCendR as we
continue to advance the company programs.” said Erkki Ruoslahti, M.D., Ph.D., Founder,
President, Chief Executive Officer and Chairman of DrugCendR. Mrs Henson, an independent
board member, is the Chief Financial Officer of Respivant Biosciences. Her previous experience
includes serving as the Chief Financial Officer of Kura Oncology and Wellspring Bioscience.

DrugCendR Inc. 2019


About the CEND1-001 Clinical Trial

CEND1-001 is an open label, multicenter (4 hospitals in Australia), safety, pharmacokinetic and


pharmacodynamic study in patients diagnosed with metastatic pancreatic adenocarcinoma. The
study will assess the safety of the combination with gemcitabine and Abraxane, and determine
an optimal biologic dose level for future studies. The principle for co-administrating CEND-1
with anti-cancer agents is that through enhancing their tumor penetration, the efficacy of the
therapies is increased, while their toxicities are decreased.

About CEND-1

DrugCendR’s proprietary technology platform is a based on a bifunctional molecular mimicry


agent CEND-1. The agent is able to manipulate the tumor microenviroment, effectively making
it into a temporary drug conduit. This allows an enhanced delivery and efficacy of various types
of co-administered anti-cancer compounds. The action is tumor-specific, thanks to the tumor-
homing RGD motif of the molecule. To date the compound has been investigated, by the
company founders and by numerous independent groups, in more than 150 publications and it
has shown efficacy in more than 40 different cancer models.

About DrugCendR

DrugCendR Inc. is a privately held biopharmaceutical company founded in 2015. The company
was spun out of the laboratory of Dr. Erkki Ruoslahti of Sanford Burnham Prebys Medical
Discovery Institute. The initial focus of company’s technology is pancreatic cancer because, in
addition to its poor prognosis, it is characterized by a dense extracellular matrix stroma, which
acts as a physical barrier to drug entry. Since the active transport process initiated by CEND-1
overcomes this obstacle, and the target receptors for are highly expressed in advanced
pancreatic cancer, CEND-1 appears particularly well suited to target PDAC. The company is
planning for additional clinical trials in other cancer indications for its lead program and has
already started a follow-up CEND-2 program, which works through a well-validated immune-
oncology pathway.

For more information please contact:


Harri Jarvelainen, COO
harri.jarvelainen@drugcendr.com

DrugCendR Inc. 2019

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